Temperature and Humidity Mapping Services—GxP-Compliant and Reliable

Temperature mapping is the systematic process of measuring and documenting temperature and humidity variations within storage or transport environments, such as warehouses, cold rooms, freezers, or transport vehicles. In the pharmaceutical industry, where many products are highly sensitive to temperature fluctuations, temperature mapping is essential for ensuring that conditions consistently remain within validated ranges.

It serves several key purposes:

• Regulatory compliance: Temperature mapping helps companies meet strict pharmaceutical regulations and guidelines, including GxP requirements, by proving that storage and transport environments are suitable for sensitive products.
• Identification of risks: Mapping identifies hot and cold spots or areas of uneven air distribution in warehouses, vehicles, or equipment, which could compromise product stability.
• Quality assurance and audit readiness: The data collected forms the foundation for quality management systems, internal controls, and regulatory audits, demonstrating that products are handled safely and consistently.

Why it matters: By understanding environmental variations and controlling risks, pharmaceutical companies can protect product efficacy, patient safety, and brand integrity while maintaining compliance with international standards.

The number of data loggers/sensors required depends on the volume of the room or equipment.

• For a system with a volume of up to 2m³, 9 data loggers are required.
• For a system with a volume of up to 20m³, the minimum number of data loggers is 15.
• For systems with a volume exceeding this, ELPRO follows the ISPE guidelines. The ISPE specifies that data loggers must not be more than 9 meters apart.

Conducting temperature mapping involves a systematic process to assess the temperature distribution within a specific area, such as a storage room, freezer, or transport container. Here are the key steps involved in conducting temperature mapping:

1. Define objective and scope

• Determine the purpose of the mapping (e.g., regulatory compliance, product stability).
• Identify the specific area or equipment to be mapped, such as refrigerators, freezers, or larger rooms.
• Assess the temperature-sensitive products or materials within the mapped area in order to define acceptance criteria.

2. Design the mapping plan

• Develop a mapping plan that outlines the number and placement of temperature sensors or data loggers. The layout should cover all critical areas, including high-risk zones such as doors, corners, and shelves.
• Use a grid or systematic approach to ensure all areas are adequately covered. The placement of sensors should account for airflow patterns and potential hot or cold spots.
• Consider environmental factors (e.g., ambient temperature, humidity) that may affect temperature variation.

3. Select the appropriate measuring equipment (data logger)

• Choose the right type of data loggers or probes based on temperature/relative humidity range, precision, and regulatory requirements.
• Ensure that data loggers have the necessary calibration certificates, such as ISO 17025, for accuracy.

4. Place the sensors or data loggers

• Position the sensors at the identified points in the mapping plan. Depending on the environment, this could include placing loggers at varying heights (top, middle, bottom), near doors, or in areas with poor airflow.
• In larger areas, sensors may need to be placed at multiple points to capture temperature variation across the entire space.
• Document data logger placement accordingly.

5. Start the mapping process

• Activate the data loggers to begin recording temperature data over the desired mapping duration.
• Document start of mapping date and time accordingly.

6. Monitor and adjust during the mapping process

7. Retrieve and analyze the data

• Once the mapping is complete, retrieve the data from the loggers.
• Analyze the data to identify any temperature fluctuations, hot/cold spots, and areas where temperature control may be insufficient.

8. Generate the mapping report

• Based on the analysis, create a GxP-compliant report that includes detailed temperature data, observations, and conclusions.
• The report should highlight any deviations from the required temperature range and provide recommendations for corrective actions if needed.
• Provide recommendations on the placement of data loggers for continuous monitoring.

9. Implement improvements (if necessary)

• If temperature deviations are found, consider adjusting equipment, optimizing airflow, or making changes to the storage layout.
• Re-map the area if significant changes are made to ensure compliance is maintained.

Temperature mapping is a critical process in ensuring regulatory compliance and maintaining the integrity of temperature-sensitive products. It helps identify any potential risks or inefficiencies in temperature control, allowing for timely corrective actions to ensure optimal conditions.

Several international regulations and guidelines address temperature mapping in GxP environments to ensure compliance, product integrity, and patient safety. These include:

1. Good Manufacturing Practice (GMP) regulations

• EU GMP Annex 15 (Qualification and Validation): Requires temperature mapping for storage areas, ensuring they maintain controlled conditions.
• WHO Technical Report Series (TRS) 961, Annex 9: Provides guidelines for qualification of storage areas, including temperature mapping.
• US FDA 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals): Requires environmental control and validation of storage conditions.

2. Good Distribution Practice (GDP) guidelines

• EU GDP Guidelines (2013/C 343/01): Mandate temperature mapping for warehouses, cold rooms, and transport systems to ensure proper storage conditions.
• WHO Guideline TRS961 Annex 9: Provide a framework for maintaining the quality of pharmaceutical products during storage and distribution.
• ISPE Good Practice Guide Controlled Temperature Chambers: Provides guidance on good practices for the mapping of controlled temperature chambers, warehouses, and refrigerated storage areas used to store raw material, work in progress, or finished product. It is intended to be used when specifying commissioning and qualification activities.

3. ISO standards

• ISO 17025: Specifies calibration and validation requirements for temperature mapping equipment (e.g., data loggers).
• ISO 9001: Includes quality management requirements that influence mapping procedures and documentation.

4. United States Pharmacopeia (USP)

• Chapter <1079>: Covers Good Storage and Distribution Practices for ensuring controlled conditions in pharmaceutical storage and transportation.
• Chapter <659>: Defines temperature ranges for the storage of pharmaceutical products

5. Other industry-specific regulations

• ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients): Requires proper storage conditions, making temperature mapping essential.
• MHRA Guidance (UK): Aligns with EU GDP requirements, including temperature mapping for regulated environments.

Regulations require temperature mapping to be conducted at regular intervals and whenever significant changes occur (e.g., facility modifications, new storage equipment). GxP-compliant documentation must be maintained, and mapping must follow a risk-based approach to ensure compliance with global standards.

ELPRO provides temperature mapping solutions that help meet these international regulatory requirements efficiently.

The frequency of temperature mapping depends on regulatory requirements, risk assessments, and operational changes. In general, it should be performed:

1. Initial qualification

• When a new storage area, equipment, or transport system is put into operation.
• After major modifications to storage areas, HVAC systems, or racking layouts.

2. Periodic re-mapping

• Verification of the necessity of a re-mapping annually or every two years
• Re-mappings depending on specifications on internal SOP.

3. After significant changes

• If new storage conditions are introduced (e.g., adding or removing equipment).
• If temperature excursions or anomalies are detected in routine monitoring.
• After facility renovations, HVAC maintenance, or system failures that could impact temperature distribution.

4. Seasonal mapping

By following a risk-based approach, companies can determine the appropriate mapping frequency to maintain compliance, product quality, and patient safety. ELPRO provides comprehensive temperature mapping services to help meet these requirements efficiently.

The main difference between temperature monitoring and temperature mapping lies in their purpose and application:

Temperature Monitoring refers to the continuous tracking of temperature in a specific location or environment over time. This process typically involves using data loggers, sensors, or real-time monitoring systems that provide ongoing data to ensure the temperature stays within the required range. Temperature monitoring is often used to maintain compliance with regulatory standards, to detect temperature excursions, and to ensure the stability of sensitive products, such as pharmaceuticals, during storage or transportation.

Temperature Mapping, on the other hand, involves a one-time or periodic process of assessing the temperature distribution across a given area. It is typically performed in larger environments, such as rooms, warehouses, or freezers, to identify potential hot or cold spots that could affect product quality or compliance. Temperature mapping creates a detailed temperature profile of the area by placing multiple sensors or data loggers in different locations to measure temperature variation within the space. The results help optimize storage conditions and inform decisions about equipment placement or operational changes.

As a result of the temperature mapping, temperature-critical locations are identified, allowing for informed recommendations on where to place continuous monitoring probes.

In summary, temperature monitoring ensures ongoing control and alerts for temperature changes, while temperature mapping provides a snapshot of temperature variation across an environment to ensure uniform conditions. Both are crucial for maintaining compliance, but mapping is typically a more detailed, one-off assessment, whereas monitoring is a continuous process.

Temperature mapping in GxP environments relies on specialized equipment to ensure compliance, accuracy, and reliability.

Key equipment includes single-use or multi-use data loggers that record temperature and/or relative humidity. These data loggers are available for various temperature ranges, including ultra-low temperatures. ELPRO LIBERO data loggers, which are used for mappings, can measure temperature ranges from -200 °C to +400 °C.

All ELPRO LIBERO data loggers are calibrated prior to the mapping study in order to demonstrate linearity throughout the measuring range. Reference standards are calibrated by an ISO 17025 (2017) accredited laboratory and are therefore traceable to international standards (e.g. SCS, NIST, UKAS, DAkkS).

Read-out of the LIBERO data loggers is feasible via the USB-port for single-use devices. Multiple-use devices can also be read-out via Bluetooth.

According to WHO guidelines, a mapping data logger should measure temperature with an accuracy of max. +/- 0.5 °C. ELPRO LIBERO data loggers ensure compliance with this requirement.